Cromolyn Sodium
CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4% Sterile
Approved
Approval ID
9616c0b9-c22a-4b0a-b379-376fa51beb05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cromolyn Sodium
PRODUCT DETAILS
NDC Product Code71205-085
Application NumberANDA074706
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateDecember 1, 2018
Generic NameCromolyn Sodium
INGREDIENTS (4)
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
Cromolyn SodiumActive
Quantity: 40 mg in 1 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT